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March 17, 2014 By: galadmin

Xarelto Makers Accused of Concealing Risk of Stroke

A Kentucky woman has sued the makers of the anticoagulant drug, Xarelto, accusing them of failing to adequately warn that it can cause irreversible bleeds, stroke and blood clots.

The lawsuit, pending in the U.S. District Court for the Eastern District of Pennsylvania, says the drug maker also failed to conduct adequate pre-clinical testing, as well as post marketing surveillance, to determine Xarelto’s safety.

Xarelto (rivaroxaban) is an oral anticoagulant manufactured by Bayer. Unlike its rival warfarin, there is currently no specific way to reverse the anticoagulant effect of rivaroxaban in the event of a major bleeding episode, which can result in death.

Virginia G. Stuntebeck filed a product liability lawsuit against Johnson & Johnson’s Janssen Pharmaceuticals Inc., Bayer Corp., and Bayer Healthcare LLC in the Philadelphia County Court of Common Pleas, alleging that she almost bled to death after she ingested Xarelto in July 2012, which was prescribed for her atrial fibrillation. She alleges the Xarelto caused her to suffer severe internal and gastrointestinal bleeding, for which she was hospitalized for several days in February 2013. Defendants removed the suit to federal court on February 24th.

“Due to the defective nature of Xarelto, persons who were prescribed and ingested Xarelto, for even a brief period of time, were at increased rate for developing life-threatening bleeds,” plaintiff alleges. “Due to the flawed formulation of Xarelto, which according to defendants does not require regular monitoring or frequent doctor follow-up, raises concerns about the risk of stroke, bleeding and blood clots if not taken properly or absorbed properly, particularly in patients with poor renal function.”

According to the lawsuit, Xarelto led to 968 suspected adverse side effects, including 72 cases of death in Germany in the first eight months of 2013. In the first quarter of 2012, the Institute for Save Medication Practices identified 365 reports of serious, disabling or fatal injury in which rivaroxaban was the primary suspect drug, the complaint says, and this report more than doubled from the previous quarter total of 128 cases.

Stuntebeck alleges that defendants concealed their knowledge that Xarelto can cause life-threatening, irreversible bleeds, and that they failed to properly warn of the irreversible nature of the drug in its warning label, the suit says. Xarelto still does not have a “black box” warning informing patients and doctors that it can cause irreversible bleeds, plaintiff contends.

The U.S. Food and Drug Administration (FDA) approved Xarelto (rivaroxaban) in July 2011 for the reduction of blood clots, deep vein thrombosis and pulmonary embolisms following knee and hip replacement surgery. Four months later, the FDA approved Xarelto as an anticoagulant primarily used to reduce the risk of stroke and systemic emobolism in patients with non-valvular atrial fibrillation. The agency later approved the drug for treatment of deep vein thrombosis and pulmonary embolisms, as well as long-term treatment to prevent recurrence of DVT and PE.

Defendants touted Xarelto as a “therapeutic simplification and therapeutic process” because it does not require patients to undergo periodic monitoring with blood tests and because there are no dietary restrictions, the suit says.

“Defendants routinely marketed Xarelto as a ‘one size fits all’ drug. In their aggressive marketing of Xarelto, defendants misinformed patients and their healthcare providers, as to the necessity to routinely monitor any patient requiring a blood thinning agent,” plaintiff asserts. “In essence, defendants have created a new drug, Xarelto, that is not better than warfarin from a safety perspective, and, at best, perhaps slightly more convenient to use and administer. The idea of this apparently easier-to-use anticoagulant evidently appealed to physicians, who were subject to extreme marketing and promotion by defendants, but ignores patient safety.”

Plaintiff states that Xarelto’s boxed warning does not address the increased risk for serious and fatal bleeding, despite the fact that the defendants’ website states that in comparison to warfarin, patients taking Xarelto have more gastrointestinal bleeds and need more transfusions, according to the complaint.

Unlike warfarin, Xarelto does not have an FDA-approved reversal agent in the event of a bad bleed or hemorrhage, to stop the drug’s blood thinning effects. According to experts, doctors have been using emergency treatments to stop Xarelto’s bleeding side effects in an attempt to prevent serious injuries and deaths.

Physicians have been using vitamin K and plasma to reverse any bleeding problems with warfarin. Unfortunately, there is no antidote available for the direct thrombin inhibitors, such as Xarelto. Because of this, it may be impossible to prevent serious injury or death if patients suffer bleeding problems after taking Xarelto.

According to the Institute for Save Medication Practices, QuarterWatch Report, the primary reported adverse event related to Xarelto use was serious blood clot-related injury, most frequently pulmonary embolism, “the very events rivaroxaban is intended to prevent,” the suit says. This lack of efficacy for short-term users of Xarelto resulted in 44 percent of the reported adverse effects, according to the complaint.

“FDA clinical reviewers have stated that ‘rivaroxaban should not be approved unless the manufacturer conducts further studies to support the efficacy and safety of rivaroxaban’ and the FDA website notes that ‘adverse event reports of thrombocytopenia and venous thromboembolic events were identified’ in relationship to Xarelto,” the suit says. “However, this information was not portrayed in the warning section on the warning label.”

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